Internalizing Production


Waddell Group was contacted by the CEO of a mid-size company that relied on a third-party vendor to supply the core components of its entire Class III product line, including mechanical heart valves. The vendor was showing signs of supply shortage, as they were struggling to fulfill the client’s orders. Because of this, the client decided to internalize production to ensure the supply of this crucial component wasn’t at risk in the future.

The CEO tasked us with leading a technology transfer while ramping up manufacturing on an aggressive schedule that mitigated any product backlog. The project deadline was restricted by the already short supply of the Class III core components needing to be replenished with a temporary pause in production as it was shifted internally.


We led the effort of defining the objectives of the technology transfer and timeline while accounting for the resources available to the team. After defining the plan and schedule, an aggressive hiring strategy was implemented that resulted in 80 new engineers and technicians being added to the firm in a three-month period. Waddell Group defined the hiring process to ensure it was efficient enough to match the high intensity of the hiring period.

The technology transfer, which was also on a tight schedule, required verification and validation to guarantee compliance with quality standards that Class III components demand. The client’s product catalog required components of multiple sizes and classifications, all of which required near-perfect execution for patient safety. We validated the entire production process while implementing a just-in-time manufacturing system.


We worked cross-functionally with the marketing and sales departments to define and drive the manufacturing schedule while achieving manufacturing ramp-ups that resulted in zero product backlog for all SKUs. The product catalog was refined to consist of product categories with as few as 19 parts, a significant decrease from when they were working with a third-party vendor.

The shift to internalized production was a success, as the client had the capacity to control the production of the Class III components without a backlog. Our team completed the project on time and under budget, and led a smooth transition from Waddell project leadership to a full-time facility vice president.


Our team of skilled project managers and leaders can set a schedule and lead the transition towards supply independence while meeting strict deadlines and scope. Internalizing production is a great way to control quality and cost by eliminating your dependence on third parties at risk of supply shortages, especially in the global supply chain environment that the market is currently experiencing. Contact Waddell Group today to get in touch with our team. Regardless of your organization’s size or location, an experienced Waddell consultant can set your project up for success.

Date: 27 April, 2016

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